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Stephanie Connolly
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Mayo Clinic enrolls first patient for ExThera Medical’s PURIFY-RCT II trial

MARTINEZ, Calif. – ExThera Medical Corporation’s PURIFY-RCT II trial to evaluate the efficacy of pathogen removal from severely ill patients suffering from pathogen shock is moving forward with the first patient enrollment at Mayo Clinic.  This comes after ExThera Medical completed the first phase of the prospective interventional multicenter PURIFY-RCT trial, where pharmacokinetic/ pharmacodynamic safety was demonstrated.  This means the Seraph 100 blood filter treatment does not reduce bloodstream concentrations of tested anti-infective medications that are currently used as a critical frontline/standard of care treatment against bloodstream infections.

“Having successfully completed the PK/PD phase of the PURIFY-RCT trial, we are excited to begin enrolling patients to further demonstrate efficacy of Seraph 100 in the treatment of pathogen-induced septic shock,” said Erin Borger, CEO of ExThera Medical. “Enrolling the first patient in this phase of the trial is a crucial milestone toward commercial availability and growth in this therapy space.”

The Seraph 100 enables infection source control through rapid extracorporeal blood filtration of pathogens and has been granted multiple Breakthrough Device Designations for patients suffering from life-threatening bloodstream infections, having been deemed a “First-In-Class” medical device by the U.S. FDA.

“Reducing pathogens from blood stream infection patients in the ICU addresses a tremendous unmet need,” said Mink Chawla, M.D., and Chief Medical Officer of ExThera Medical. “We are excited about the prospects of this study, and if successful, this investigational treatment can be used for patients where anti-infective drugs are inadequate or to combat the next pandemic.”

The PURIFY-RCT trial is sponsored by the Department of Defense in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health Sciences to evaluate the safety and efficacy of the Seraph^® 100 Microbind^® Affinity Blood Filter. The clinical trial will be conducted in centers across the United States, targeting improvements in both clinical outcome and health economic endpoints.

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About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the U.S., the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. 

The Seraph 100 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information, visit the company’s website at http://www.extheramedical.com/.

About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph^® 100 Microbind^® Affinity Filter (Seraph 100), it passes through a bed of small beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Many harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph 100 adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.

For more news stories on Seraph 100 and ONCObind, click here.

Disclaimer
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.

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